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Home » Newsletters » BioWorld

BioWorld

April 4, 2024

View Archived Issues
Lung cancer illustration

Effector stock wilts as phase II cancer data disappoint

Top-line data from the phase II Kickstart study of Effector Therapeutics Inc.’s tomivosertib as a frontline treatment of non-small-cell lung cancer failed to produce data strong enough to continue development in the indication. The company has decided to halt the study, move ahead with a separate, investigator-sponsored study of tomivosertib in acute myeloid leukemia and focus on another drug in its pipeline for treating breast cancer. Effector’s stock (NASDAQ:EFTR) crumpled on the NCSLC news as shares plunged 82% on April 4 to close at $2.96 each. The closing value was the lowest the company has seen in the past 12 months. Read More
Staphylococcus-aureus-staph-bacteria-infection.png

US FDA approves antibiotic Zevtera, Basilea seeks US partner

In a long and winding regulatory road that began with two complete response letters 15 years ago, Allschwil, Switzerland-based Basilea Pharmaceutica Ltd. finally gained U.S. FDA approval of its intravenous cephalosporin antibiotic, Zevtera (ceftobiprole medocaril sodium), to treat Staphylococcus aureus bacteremia, acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia. Read More
Magnifying glass, FDA concept image

US FDA struggling to keep up with clinical research inspections

The lingering effects of the COVID-19 pandemic and ongoing recruitment/retention issues are making it difficult for the U.S. FDA’s bioresearch monitoring program to keep up with the on-site clinical research inspections that are a cornerstone of the preapproval process for new drugs, biological products and medical devices. The resulting delays could threaten the approval timelines for many products. Read More

Candel waxes to 52-week high on phase II pancreatic cancer data

Positive updated phase II data with CAN-2409 in pancreatic cancer led shares of Candel Therapeutics Inc. (NASDAQ:CADL) to close April 4 at $6.40, up $4.72, or 281%, well above the firm’s previous 52-week high. At one point during the day, the stock had climbed to $7.65. Read More
Illustration of amyloid plaques in Alzheimer's disease

After the first approvals, where does amyloid go from here?

After decades of trying and dozens of failed trials, amyloid targeting has paid off with the first disease-modifying agents reaching the market. But success does not mean slam dunk. Aduhelm (aducanumab, Biogen Inc.) was dogged by controversy throughout its brief tenure, and Biogen pulled the plug on it in early 2024. Leqembi (lecanemab, Biogen Inc.) has received full approval. In this second installment of a three-part series on Alzheimer’s, BioWorld looks at the nuanced view of amyloid’s role in the disease. Read More

Enterobiotix closes £27M series B as microbiome field advances

Microbiome specialist Enterobiotix Ltd. has raised £27 million (US$34.2 million) in a series B round as it starts a phase II trial of EBX-102-02 in the treatment of irritable bowel syndrome. Read More

Ahead of IPO, D&D Pharmatech wins US fast track for MASH drug

Building D&D Pharmatech Inc. has been a rollercoaster ride, according to CEO Seulki Lee. The U.S. and Korea-based biotech is on another ascent, having scored U.S. FDA fast track designation for its metabolic dysfunction-associated steatohepatitis (MASH) drug, ahead of its third attempt at a public listing. Read More

Amylyx pulling ALS drug Relyvrio from US, Canadian markets

Less than a month after disclosing that its confirmatory phase III trial of Relyvrio (sodium phenylbutyrate plus taurursodiol) fell short of its endpoint, Amylyx Pharmaceuticals Inc. is withdrawing the amyotrophic lateral sclerosis (ALS) drug from the market. Read More

Appointments and advancements for April 4, 2024

New hires and promotions in the biopharma industry, including: Adaptive, Alterome, Ligand, Nextcure, Obsidian, Opthea. Read More

In the clinic for April 4, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Alto, Daiichi, Denovo, Enterobiotix, Fibrogen, Harmony, Lenz, Merck & Co., Nanobiotix, Neurocrine, Ractigen, Tracon, VBI. Read More

Other news to note for April 4, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: I-Mab, Splisense. Read More

Regulatory actions for April 4, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ARS, BMS, Can-Fite, Convergent, Inhibikase, Lipella, Remegen, Soligenix, Splisense, TME, Vanda. Read More

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